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Radioimmunoassay, Cortisol

Regulation 862.1205

0510(k)s in 12 months (84 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in CGR

Company510(k)sRecalls
Beckman Coulter, Inc.36
Diagnostic Products Corp.50
Corning Medical & Scientific30
Diagnostic Systems Laboratories, Inc.30
Nichols Institute Diagnostics30
Nuclear Medical Laboratories, Inc.30
Amersham Corp.20
Bd Becton Dickinson Vacutainer Systems Preanalytic20
Bio-Rad Laboratories, Inc.20
Biotecx Laboratories, Inc.20
DateFirm and productCodeLinked 510(k)
Oct 21, 2025Beckman Coulter, Inc.
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
Open, Classified		 CGRK242190
Oct 2, 2025Beckman Coulter Inc.
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
Open, Classified		 CGRK242190
Nov 6, 2024Beckman Coulter, Inc.
The Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Acce
Open, Classified		 CGRK223038
Sep 18, 2018Beckman Coulter Inc.
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a paramagnetic particle, chemiluminescent immuno
Terminated		 CGRK023764
K050202
Oct 23, 2014Siemens Healthcare Diagnostics
IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measur
Terminated		 CGRK931409
Jul 8, 2011Beckman Coulter Inc.
Active Cortisol EIA, 96 Wells, DSL-10-2000 The DSL-10-2000 Active Cortisol Enzyme Immunoassay (EIA) kit provides materials for the quantitative measurement of cortisol in serum, plasma or urine. This
Terminated		 CGRK884689
Sep 29, 2010Beckman Coulter Inc.
Access Immunoassay Systems CORTISOL, Part Number: 33600
Terminated		 CGRK954733

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